Round 1 - Foundation for Innovative New Diagnostics

More documents

Recommendations

Info

Table A4.5a: Distribution of Pan/Pv test band intensity (0-4) scores for P. vivax (n=20) samples at low and high parasite densities (parasites/μl) samples based on a delayed reading according to manufacturers recommendation Table A4.6: Detection rate of P. falciparum in low (200) and high (2000 or 5000) parasite densities (parasites/μl) by continent Table A4.6a: Detection rate of P. falciparum in low (200) and high (2000 or 5000) parasite densities (parasites/μl) by continent based on a delayed reading when specified by the manufacturer Table A4.7: P. falciparum test line false positive results for P. vivax samples (n=20) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) Table A4.7a: P. falciparum test line false positive results for P. vivax samples (n=20) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer Table A4.8: Combination test pan line false positive non Pf infection on P. falciparum samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) Table A4.8a: Combination test pan line false positive non Pf infection on Pf samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer Table A4.9: False positive rate of P. falciparum (or pan) test line results on all malaria-negative samples Table A4.9a: False positive rate of P. falciparum (or pan) test line results on all malaria-negative samples based on a delayed reading when specified by the manufacturer Table A4.10: False positive rate of P. falciparum (or pan) test line results for samples containing specific non-malarial infectious pathogens Table A4.10a: False positive rate of P. falciparum (or pan) test line results for samples containing specific non-malarial infectious pathogens based on a delayed second reading when specified by the manufacturer Table A4.11: False positive rate of P. falciparum (or pan) test line results for samples containing potentially cross-reacting blood immunological factors Table A4.11a: False positive rate of P. falciparum (or pan) test line results for samples containing potentially cross-reacting blood immunological factors based on a delayed reading when specified by the manufacturer Table A4.12: False positive rate of pan/Pv test line results on all malaria-negative samples Table A4.12a: False positive rate of pan test line results on all malaria-negative samples based on a delayed second reading when specified by the manufacturer Table A4.13: Heat stability testing results for P. falciparum test line on P. falciparum samples at low parasite density (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table A4.13a: Heat stability testing results for pan test line of combination RDTs on P. falciparum samples at low parasite density (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table A4.14: Heat stability testing results for P. falciparum test line on P. falciparum samples at high parasite density (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table A4.14a: Heat stability testing results for pan test line of combination RDTs on P. falciparum samples at high parasite density (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table A4.15: Heat stability testing results for P. falciparum (or pan) test line on parasite negative samples. Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table A4.15a: Heat stability testing results for pan test line of combination RDTs on negative samples. Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C Table A6.1: Example malaria RDT implementation budget IV Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
Acknowledgements The evaluation described in this report was a joint project of the WHO Regional Office for the Western Pacific (WPRO), the Foundation for Innovative New Diagnostics (FIND), TDR, Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO and the US Centers for Disease Control and Prevention (CDC), under the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND, the Australian Agency for International Development (AusAID), the United States Agency for International Development (USAID) and TDR. The project would not have been possible without the cooperation and support of the specimen collection sites, and the specimen characterization laboratories mentioned herein. The project acknowledges the technical advice from many malaria diagnostic manufacturers and developers in the development of the programme. The WHO-FIND Malaria RDT Evaluation Programme is grateful to all those who contributed to the conduct of the evaluation and preparation of this report. Salim Abdullah Audrey Albertini Frederic Ariey John Barnwell David Bell Qin Cheng Peter Chiodini Jane Cunningham Linda Dantes Djibrine Djalle Dionicia Gamboa Michelle Gatton Iveth Gonzalez Beatrice Gordis Sandra Incardona Jean Joly Sophie Jones Derryck Klarkowski Myat Phone Kyaw Jennifer Luchavez Lucian Marts James McCarthy Didier Menard Claribel Murillo Bernhards Ogutu Wellington Oyibo Rosanna Peeling Anita Pelecanos Mark Perkins Charuni Senanayake Michael Valentine Melissa Vega Ifakara Health Research and Development Centre, Tanzania FIND, Switzerland Institut Pasteur, Cambodia US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA WHO – Regional Office for the Western Pacific, Philippines Army Malaria Institute, Australia Hospital for Tropical Diseases, United Kingdom TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland WHO – Regional Office for the Western Pacific, Philippines Institut Pasteur Bangui, Central African Republic Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru Queensland Institute of Medical Research, Australia FIND, Switzerland FIND, Switzerland Consultant, FIND, Switzerland TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA Médecins Sans Frontières, Netherlands Department of Medical Research, Myanamar Research Institute of Tropical Medicine, Philippines US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA Queensland Institute of Medical Research, University of Queensland, Australia Institut Pasteur de Madagascar, Madagascar Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Colombia Kenya Medical Research Institute (KEMRI), Kenya University of Lagos, Nigeria TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland Queensland Institute of Medical Research, Australia FIND, Switzerland WHO – Regional Office for the Western Pacific, Philippines US Centers for Disease Control and Prevention / National Center for Infectious Diseases , USA TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008) V
Page 1: Malaria Rapid Diagnostic Test Perfo
Page 4 and 5: WHO Library Cataloguing-in-Publicat
Page 6 and 7: 10.3. Phase 2 - Wild type P. falcip
Page 8 and 9: Figure 24: Figure 25: Figure 26: Fi
Page 12 and 13: Abbreviations ACT AMI Artemisinin-b
Page 14 and 15: Figure E1: Summary performance of m
Page 16 and 17: and sometimes poor study methods, a
Page 18 and 19: 4. Materials and methods 4.1. Test
Page 20 and 21: Figure 4a: Origin of P. falciparum
Page 22 and 23: c. Ease of use assessment: After be
Page 24 and 25: 7. Ethical considerations Each spec
Page 26 and 27: 10. Results 10.1. Summary In Round
Page 28 and 29: Table 3a: Summary performance of ma
Page 30 and 31: Table 4a: Summary performance of ma
Page 32 and 33: 10.2. Phase 1 - P. falciparum cultu
Page 34 and 35: 10.3.2. P. vivax detection rate P.
Page 36 and 37: Figure 11: Phase 2 † wild type P.
Page 38 and 39: Figure 13: P. falciparum (P. falcip
Page 40 and 41: Figure 15: Plasmodium spp. (pan or
Page 42 and 43: Figure 18: Wild type P. falciparum
Page 44 and 45: 11. Heat stability A single P. falc
Page 46 and 47: Figure 25: Heat stability of pan-li
Page 48 and 49: Table 6: Ease of use description of
Page 50 and 51: 13. Discussion of key findings simu
Page 52 and 53: under field conditions, loss of par
Page 54 and 55: 14.2. Lot testing Complementary to
Page 56 and 57: 44 Malaria Rapid Diagnostic Test Pe
Page 58 and 59: Manufacturer Access Bio, Inc. ACON
Page 60 and 61:
Manufacturer Innovatek Medical Inc.
Page 62 and 63:
Manufacturer ICT Diagnostics Span D
Page 64 and 65:
Manufacturer Product name Plasmodiu
Page 66 and 67:
Type B: Malaria Generic Major Plasm
Page 68 and 69:
Type D: Malaria Generic Pf-Pan RDT
Page 70 and 71:
Annex 3: Phase 1 Results Table A3.1
Page 72 and 73:
Table A3.2: Detection rate of 20 P.
Page 74 and 75:
Table A3.3a: Distribution of test b
Page 76 and 77:
P. falciparum samples (n=79) P. viv
Page 78 and 79:
Table A4.2: Reader variability in d
Page 80 and 81:
Table A4.4: Distribution of test ba
Page 82 and 83:
Table A4.5: Distribution of pan/Pv
Page 84 and 85:
200 parasites/µl 2000 or 5000 para
Page 86 and 87:
Table A4.7a: P. falciparum test lin
Page 88 and 89:
Table A4.9: False positive rate of
Page 90 and 91:
Table A4.10 False positive rate of
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Table A4.13: Heat stability testing
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
ANNEX 5: Example algorithm for sele
Page 104 and 105:
ANNEX 6: INTRODUCING RDT-BASED MALA
Page 106 and 107:
Recommended sequence of activities
Page 110:
ISBN 978 92 4 159807 1 DOI: 10.2471
show all

Round 1 - Foundation for Innovative New Diagnostics

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?